HESI Insights - January 2024

This year marks HESI’s 35th anniversary. HESI science has been implemented around the world to improve decision making, enhance human health and safety, and preserve the environment. Looking forward to the next 35 years, HESI is excited to continue creating a collaborative environment for scientists from academia, government, industry and NGOs to come together to create science based solutions for a safer more sustainable world.

To learn more about HESI, view our annual reports and monthly newsletters from past years and reach out to get involved!

The HESI Genetic Toxicology Technical Committee is pleased to highlight their Nitrosamines Research Program (NRP). Under the auspices of their Mechanism-Based Genotoxicity Risk Assessment Working Group which aims to demonstrate the usefulness of innovative, mechanism-based testing approaches, the NRP will address knowledge gaps regarding the safety of patients exposed to drugs contaminated with nitrosamine impurities. These impurities are of significant concern since nitrosamines as a class are considered potent mutagenic carcinogens that may increase the risk of cancer if people are exposed to them above acceptable levels.

The NRP has grown since its launch in 2022 and now include four key aims: (1) to develop a protocol for an optimized Ames assay to predict the carcinogenicity of nitrosamines; (2) identify and verify in vitro assays with metabolically competent cells to support nitrosamines risk identification; (3) develop a possible in vivo follow-up strategy to verify Ames data within the frame of ICH M7 and, (4) refine and extend the Carcinogenic Potency Categorization Approach (CPCA) using (Quantitative) Structure–Activity Relationship [(Q)SAR] models and Quantum Mechanics (QM) for more predictive and accurate predictions.

The (Q)SAR-QM working group is just launching, and you can learn more about the proposed aims here.

An overview of the NRP can be found on the Nitrosamines webpage here.

For more information or to get involved please contact Connie Chen and Raechel Puglisi.

COMPARE 2024, the eighth iteration of the COMprehensive Protein Allergen REsource, is now available! COMPARE is a transparent resource, publicly accessible, for identifying protein sequences that are known allergens, contributing valuable information to the field of allergen research and safety assessment for novel foods. It is being used worldwide, by over 4,500 users across all continents.

The new release contains 2,748 entries and a new graphical representation for viewing sequence fragments. It takes 9 months and collaboration with multiple international stakeholders from public and private sector (including end-users; bioinformaticians; molecular allergologists and allergy clinicians) to put together each new version.

Check-it out! https://comparedatabase.org/

The Cardiac Safety Steering Team is proud to present the 2024 webinar series featuring Early Career Seminar Series Awardees. This competitive award is given to postdoctoral or early career scientists who have compelling research related to cardiovascular safety and risk assessment. Save the dates for this year’s seminars!

Three awardees were selected for the 2024 Seminar Series:

• Dr. Chon Lok Lei, February 22 at 9am ET
• Dr. Victoria Au Yueng, March 22 at 11am ET
• Dr. Alexandra Schaffert, April 5 at 11am ET

Details can be found in the Upcoming Events section below.

Congratulations to Dr. Scott Auerbach of the National Institute of Environmental Health Sciences, National Toxicology Program, on receiving the 2024 Society Of Toxicology (SOT) Arnold J. Lehman Award.

This award recognizes an SOT member who has made a major contribution to risk assessment and/or the regulation of chemical agents, including pharmaceuticals.

Dr. Auerbach has been a HESI member for over a decade. He is involved in the HESI Botanical Safety Consortium Data Analysis Group, the Transforming the Evaluation of Agrochemicals (TEA) Committee and is Chair of the Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee and member of the Carcinogenomics, Error Corrected Sequencing and Transcriptomic Point of Departure for Chemical Risk Assessment working groups. Congratulations Scott!

The HESI Botanical Safety Consortium collaborates to develop screening strategies that can efficiently identify botanical-induced toxicity. The study presented here evaluates the applicability of in vitro multi-well microelectrode array (MEA) recordings for screening and prioritizing botanical extracts for their neuroactive potential. To this aim, 16 botanical extract materials were tested for their effects on mitochondrial activity and neuronal activity upon acute exposure. Most botanical extracts tested in this study inhibit neuronal activity in vitro. Results show that MEA recordings in rat cortical cultures provide an efficient tool for screening the neurotoxicity of botanical extracts. Further testing is required to derive full dose-response curves and mechanistic insight.

Read full article here: https://doi.org/10.1016/j.fct.2024.114438

Learn more about the Botanical Safety Consortium here.

The HESI Board convened on January 23rd and 24th for an in-person session filled with enthusiasm. Amidst the agenda items were a deep dive into 2023’s triumphs, the green light for the 2024 budget, and the strategic plotting of the organization’s future. Executive Director Syril Pettit and Deputy Director Michelle Embry brought a sparkle to the gathering as they highlighted HESI’s stellar accomplishments over the past six months, particularly in the realms of special programs Thrive, Health DataWell, and GRATC.

The buzz in the room wasn’t just about numbers; it was about the vibrant pulse of growth in membership, program reach, funding diversity, and the broadening topical scope that HESI is embracing. From grade-school education to training initiatives in low- and middle-income countries, HESI is not just thriving but making a meaningful impact. The discussion soared beyond routine boardroom chatter as they explored inventive ways to fortify HESI’s strengths and expand its influence. A Shark Tank/Dragons’ Den round of brainstorming generated many exciting ideas for the upcoming 2025 HESI Scientific Conference. Keep an eye out for the winning idea to be announced this June!

The magic of HESI, it seems, lies in its ability to wield scientific prowess in unconventional ways, from engaging kids in the wonders of science to empowering communities worldwide. The Board, fired up by this energy, urged everyone to keep the creative juices flowing, pondering where HESI’s scientific model could venture next.

And of course, kudos were in order for the fantastic mix of minds steering the HESI ship. Comprising 15 public sector and 14 private sector representatives, the Board’s dedication to HESI’s mission of developing science-based solutions for a safer, more sustainable world deserves a standing ovation. Here’s to these brilliant minds shaping a future where science meets impact.

For more information on these efforts, please contact HESI (hesi@hesiglobal.org).

HESI Senior Scientific Program Manager Connie Mitchell will present at a webinar hosted by the Environmental Mutagenesis and Genomics Society.

This webinar will introduce the work by the non-profit Health and Environmental Sciences Institute (HESI) in addressing global health and environmental challenges through fostering collaborations between scientists from academia, government, industry, and NGOs.

Registration is for EMGS members only and can be found on the event page here.

Please join us for our first FREE webinar in the Cardiac Safety Early Career Seminar Series on February 22 at 9:00 am ET where Dr. Chon Lok Lei will present: Uncertainty in Torsade Risk due to Different Possible Kinetic Binding Mechanisms for hERG.

Bio: Chon Lok Lei is an Assistant Professor of Biomedical Sciences, a principal investigator, at the University of Macau. He completed his doctoral degree as a Clarendon scholar at the Computational Biology group in the Department of Computer Science at the University of Oxford, working collaboratively with a research team at Roche. He received his undergraduate degree and the Dean’s List in Physics from Imperial College London. He has strong research interests in mathematical and computational modelling of biological and physiological systems and their applications in cardiac safety pharmacology. His recent work provides a novel pipeline for quantifying the uncertainty in binding mechanisms and propagating to clinical risk predictions.

For webinar link contact: HESI Cardiac Safety cardiacsafety@hesiglobal.org

HESI eSTAR Carcinogenomics Project members Connie Mitchell (HESI), Keith Tanis (Merck) and Udayan Apte (University of Kansas Medical Center) are presenting a webinar to the Carcinogenesis Specialty Section of SOT.

Title: Carcinogenomics—Assessing the Tumorigenic Potential of Chemicals Through Genomic Biomarkers to Reduce the Reliance on the Rodent Cancer Bioassay

Details can be found here. Registration is required for this free webinar.

HESI’s Environmental Epidemiology Committee is hosting a webinar series to illustrate the critical role epidemiology can play in the field of quantitative risk assessment. The purpose of these presentations is to provide insight on how to best realize the full potential of human studies in risk assessment and regulatory decision making, and to feature ongoing efforts in this space.

Please, join us for our next webinar, presented by Dr. Charles Haas (Drexel University). Q&A session to follow.

Click HERE to Register

Abstract: Use of epidemiologic information to set recreational water criteria for microorganisms.

Exposure of people to infectious microorganisms occurs in a variety of venues and by different activities. Venues include saline, brackish and fresh natural waters, pools, spray parks, etc. Exposure may occur via inadvertent ingestion during contact (primary or secondary) recreation, impact of water on skin, and inhalation (with or without aspiration) from spray activities. There are a diversity of pathogens that may be of concern, although historically the focus has been on gastroenteric pathogens. US EPA has developed recreational criteria, with a focus on primary contact, from several epidemiological studies done since the 1970’s. This talk will review the underlying epidemiological studies used (in which microbiological indicator organisms were employed to assess water quality), and outline the data gaps that pure reliiance on epidemiological evidence has. The complementary approach of developing criteria using a quantitative microbial risk assessment (QMRA) approach will be discussed, and compared (with respect to both advantages and limitations) to the epidemiological approach, and some paths forward to fuse the two types of evidence indicated.

Speaker Bio: Charles N. Haas is the L.D. Betz Professor of Environmental Engineering, at Drexel University, where he has been since 1991. He received his BS (Biology) and MS (Environmental Engineering) from the Illinois Institute of Technology and his PhD in Environmental Engineering from the University of Illinois at Urbana-Champaign. He has served on the faculties of Rensselaer Polytechnic Institute and the Illinois Institute of Technology prior to joining Drexel. He co-directed the USEPA/DHS University Cooperative Center of Excellence Center for Advancing Microbial Risk Assessment (CAMRA). He is a distinguished fellow of the International Water Association, and a fellow of the American Academy for the Advancement of Science, the Society for Risk Analysis, the American Society of Civil Engineers the American Academy of Microbiology and the Association of Environmental Engineering and Science Professors. He is a Board Certified Environmental Engineering Member by eminence of the American Academy of Environmental Engineers. He has received the Dr. John Leal Award and the AP Black Award of the American Water Works Association and the Clarke Water Prize. In 2021, he was elected to the National Academy of Engineering. Over his career, Professor Haas has specialized in the assessment of risk from and control of human exposure to pathogenic microorganisms, and in particular the treatment of water and wastewater to minimize microbial risk to human health. Professor Haas has served on numerous panels of the National Academies of Sciences, Engineering and Medicine. He is a past member of the Water Science and Technology Board of the National Academies, and the US EPA Board of Scientific Counselors.

A number of HESI Committees will present at the Society Of Toxicology 2024 Annual Meeting.

We would love to connect with you! Click the link below to view complete details on where you can find us!

HESI at SOT 2024: https://connect.hesiglobal.org/gNb8am

Please save the date for our second webinar in the Cardiac Safety Early Career Seminar Series on March 11th at 11:00 am ET where Dr. Victoria Au Yueng of AstraZeneca will present.

Details will be added closer to the date!

For webinar link contact: HESI Cardiac Safety cardiacsafety@hesiglobal.org

Please join us for our final webinar in the Cardiac Safety Early Career Seminar Series on April 5th at 11:00 am ET where Dr. Alexandra Schaffert will present: Redefining Cardiotoxicity Assessment of Environmental Chemicals using Adverse Outcome Pathways.

Bio: Dr. Alexandra Schaffert is a postdoctoral researcher at the Medical University Innsbruck in Austria. She has a background in systems toxicology and her career has been focused on advancing human-relevant in vitro experimentation and reducing reliance on animal testing. Her current work under the EU H2020 Project “ALTERNATIVE” intersects regulatory science and cutting-edge toxicological research. Her efforts include investigating cardiotoxic mechanisms of environmental contaminants and developing an Adverse Outcome Pathway network for cardiotoxicity, aiming to establish an integrated approach to testing and assessment for cardiotoxicity.

For webinar link contact: HESI Cardiac Safety cardiacsafety@hesiglobal.org

The Botanical Safety Consortium will be in attendance and presenting at the 22nd International Conference on the Science of Botanicals.

Speakers include Connie Mitchell (HESI), and committee members Cynthia Rider (NIEHS), Amy Roe (P&G), Bill Gurley (University of Mississippi), and Holly Johnson (AHPA).

The Next Generation Ecological Risk Committee will be presenting at SETAC Europe.

Session: Alternatives to Animal Testing for Ecotoxicity Assessments: Exploring Approaches and Avenues for the Future.
Connie Mitchell (HESI) is co-chairing along with HESI Board of Trustees member Adam Lilicrap (NIVA) and Eco-Risk Committee members, Teresea Norberg-King (retired from US EPA) and Kristin Schirmer (EAWAG).

The Transforming the Evaluation of Agrochemical (TEA) Committee will present at the 22nd International Congress of the European Society of Toxicology In Vitro (ESTIV) taking place 3-6 June 2024.

Details will be added to the event page here.

International Congress On Natural Products Research (ICNPR), Krakow, Poland 13-17 July 2024

The Botanical Safety Consortium is holding a training course as part of the meeting on Saturday 13 July entitled “Cultivating Safety: Toxicology 101 of Botanicals and Natural Products.”

This course will offer a deep dive into the world of botanicals, bridging the gap between their traditional uses and modern applications in supplements, medicines, and cosmetics. Participants will explore routes of botanical exposure, interactions with drugs, dose-response nuances, acute and chronic toxicity, and a range of potential health endpoints. With hands-on exercises, discussion of cutting-edge toxicity assessment tools, and interactive case studies—including challenges like product adulteration and new botanical discoveries—the course will provide a comprehensive look into the complexities of botanical safety, making it essential for researchers, practitioners, and thrill seekers.

Register at www.icnpr2024.org

Speakers and training course developers include BSC members Amy Roe (P&G), Holly Johnson (AHPA), Stefan Gafner (American Botanical Council), Olaf Kelber (Bayer), Richard van Breemen (Oregan State University), Cynthia Rider (NIEHS), Connie Mitchell (HESI), Michelle Embry (HESI), and Julie Krzykwa (HESI).

Meeting flyer available here.

HESI THRIVE is a seed grant program that is innovating translational research and improving quality of life after cancer. By providing researchers with both seed funding and access to critical networks, THRIVE enhances the visibility of the patient need, the value of the research, and the reasons that larger funding entities might elect to incorporate these research streams into future funding priorities.

THRIVE provides seed grants for clinical and translational research and technology-based solutions that enhance our ability to predict when and how adverse effects may occur in patients who have received cancer treatment. The THRIVE grant program is designed to provide seed funding to investigators for the testing of initial hypotheses and collecting of preliminary data to help secure long-term funding by the National Institutes of Health (NIH) and/or other major institutions. For details on eligibility, funding, the application process, and key deadlines, please click here.

THRIVE will accept letters of intent from 13 November 2023 until 8 April 2024.

For more information, contact research@hesithrive.org.

In an ever-changing world where resources are tighter and time is more limited, HESI recognized the need to diversify funding to both address challenges affecting our day-to-day projects as well as reach for even more innovative science. In 2015, HESI secured an initial grant, which was modest but provided a source of momentum for our work. Since then, HESI has won an additional 8 grants (or contracts) both from US and European sources. It’s immensely gratifying to see our efforts translate into tangible impact, as our grant portfolio has grown to more than $5.2 million USD. This has allowed us to not only expand our programs but has enabled us to broaden our community and impact. Navigating the grant landscape has been both challenging and rewarding and I look forward to continuing to help HESI navigate this new landscape.

With kind regards,

Jennifer Pierson, MPH, Associate Director for Program Development & Resourcing